Pin, Fixation, Threaded

What Is FDA Product Code JDW?

Pin, Fixation, Threaded is FDA product code JDW, Class 2, 21 CFR 888.3040.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 286 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 100 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Packaging (52), Device Design (21) and Nonconforming Material/Component (3).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.